Committee

Committee:

CTN 91 - Implants for surgery

Secretary:
FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA
Field of Activity:
Standardization of:

Specific materials both basic and composite for implants for surgery and standardization of the required instrumentation for its implantation, covering terminology, specifications and test methods.

Excluding:

Materials and surgical instruments which are within the scope of other committees.

Note: Implants for surgery are meant objects or devices which are surgically implanted in the body either temporarily or permanently for diagnostic or therapeutic purposes.
International Relations:

ISO/TC 150  Implants for surgery

CEN/CLC/JTC 16  CEN/CENELEC Joint Working Group on Active Implantable Medical Devices

CEN/TC 285  Non-active surgical implants

Standards developed by the committee: CTN 91: 139

UNE-EN ISO 5832-3:2022

Status: VIGENTE /  2022-09-21

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)

UNE-EN ISO 9713:2022 (Ratificada)

Status: VIGENTE /  2022-03-01

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022) (Endorsed by Asociación Española de Normalización in March of 2022.)

UNE-EN ISO 16672:2021 (Ratificada)

Status: VIGENTE /  2021-11-01

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020) (Endorsed by Asociación Española de Normalización in November of 2021.)

UNE-EN ISO 16061:2021

Status: VIGENTE /  2021-10-13

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

UNE-EN ISO 25539-2:2021

Status: VIGENTE /  2021-04-28

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

UNE-EN ISO 11979-5:2021

Status: VIGENTE /  2021-04-28

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

UNE-EN ISO 5840-1:2021 (Ratificada)

Status: VIGENTE /  2021-03-01

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)

UNE-EN ISO 5840-2:2021 (Ratificada)

Status: VIGENTE /  2021-03-01

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)

UNE-EN ISO 5840-3:2021 (Ratificada)

Status: VIGENTE /  2021-03-01

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)

UNE-EN ISO 16054:2020

Status: VIGENTE /  2020-03-25

Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)

UNE-EN ISO 11979-1:2019

Status: VIGENTE /  2019-10-23

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2018)

UNE-EN ISO 14607:2018 (Ratificada)

Status: VIGENTE /  2018-12-01

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

UNE-EN ISO 16671:2016/A1:2018

Status: VIGENTE /  2018-06-20

Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)

UNE-EN ISO 11979-10:2018 (Ratificada)

Status: VIGENTE /  2018-06-01

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018) (Endorsed by Asociación Española de Normalización in June of 2018.)

UNE-EN ISO 7198:2017

Status: VIGENTE /  2017-11-29

Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)

UNE-EN ISO 11979-8:2017

Status: VIGENTE /  2017-07-26

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

UNE-EN ISO 25539-1:2017 (Ratificada)

Status: VIGENTE /  2017-06-01

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017) (Endorsed by Asociación Española de Normalización in June of 2017.)

UNE-EN ISO 16671:2016

Status: VIGENTE /  2016-01-20

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)

UNE-EN ISO 11979-6:2015

Status: VIGENTE /  2015-05-13

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

UNE-EN ISO 11979-3:2013

Status: VIGENTE /  2013-07-24

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

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